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Sanders Launches Senate Investigation Into ‘Outrageously High’ Pricing of Ozempic, Wegovy
Sen. Bernie Sanders is taking aim at the high prices of the blockbuster drugs Ozempic and Wegovy. The Vermont senator, an independent who has long called out drug manufacturers for their costly products, is launching an investigation into the “outrageously high prices” Novo Nordisk charges for the drugs.
Sanders is asking Novo Nordisk to answer whether it will “substantially reduce” the prices of the medications as well as to provide information on how much it makes from selling the drugs, how much it spent on research and development and how it determined the prices.
Novo Nordisk increased the list price for Ozempic by 3.5% this year to $969 for a four-week supply but kept the price of Wegovy unchanged at $1,349. The drugmaker told CNN in February that it increases the list prices of some medications each year based on changes in the healthcare system, inflation and market conditions.
Sanders’ letter notes that researchers at Yale University recently found that these medications “can be profitably manufactured for less than $5 a month.” Also, Ozempic costs only $155 in Canada and $59 in Germany, while Wegovy can be purchased for $140 in Germany and $92 in the United Kingdom, the senator pointed out.
GlaxoSmithKline Sues Pfizer and BioNTech Over COVID Vaccine Technology
GlaxoSmithKline (GLAX.NS) sued Pfizer (PFE.N) and BioNTech (22UAy.DE) in Delaware federal court on Thursday, accusing them of infringing GSK patents related to messenger RNA (mRNA) technology in the companies’ blockbuster COVID-19 vaccines.
GSK said in the lawsuit that Pfizer and BioNTech’s Comirnaty vaccines violate the company’s patent rights in mRNA-vaccine innovations developed “more than a decade before” the outbreak of the COVID-19 pandemic.
A GSK spokesperson said the company believes its patents “provided the foundational technology used in Pfizer and BioNTech’s COVID-19 mRNA vaccines,” and that it is “willing to license these patents on commercially reasonable terms and to ensure continued patient access” to the shots.
The lawsuit adds to a web of high-stakes U.S. court cases involving Pfizer, BioNTech and Moderna over patent royalties for technology used in their vaccines, including a case brought by Moderna against Pfizer in 2022.
GSK also sued Pfizer for patent infringement last year over technology used in Pfizer’s respiratory syncytial virus (RSV) vaccine Abrysvo. Pfizer has denied GSK’s claims in that case.
At Moderna, OpenAI’s GPTs Are Changing Almost Everything
The Wall Street Journal reported:
Moderna is looking to move beyond COVID, using its messenger RNA platform on a variety of fronts, from preventing viral illnesses to treating cancer. CEO Stéphane Bancel called the OpenAI partnership, and its use of AI in general, the key to helping the vaccine maker transform every business process: “How do we use it at scale to reinvent all of Moderna’s business processes, in science, in legal, in manufacturing — everywhere.”
So far, Moderna employees have created over 750 unique, tailored versions of OpenAI’s ChatGPT, also known as GPTs, that are designed to facilitate specific tasks or processes across the business. Some of these GPTs help select the optimal doses for clinical trials and help draft responses to questions from regulators.
The stakes are high for leveraging AI at Moderna, whose only commercial product currently is a COVID-19 vaccine. In February, it reported fourth-quarter revenue that slumped to $2.8 billion from $5.1 billion the year before as fewer people got its COVID-19 shot. AI could accelerate the delivery of much-needed new products and allow Moderna to move quickly as it aims to roll out 15 new products in the next five years, the company said.
New Studies Point to Safety of COVID Vaccines, but Leave Questions Unanswered
After more than 13 billion COVID vaccines given around the world, the largest studies to date point to the general safety of the mRNA vaccines, but questions from a small group of Minnesotans claiming vaccine injury remain unanswered.
Two days following a booster dose of the Pfizer COVID-19 vaccine, Craig Norkus says he started suffering head and body aches, severe exhaustion, and confusion, along with cool and hot tingling in his fingers and legs. Blood tests revealed his immune system was under attack, but five separate specialty doctors could not explain the source of his symptoms.
In April last year, an osteopathic doctor diagnosed Norkus with immunosuppression and small fiber neuropathy. The doctor believes the conditions were triggered by the vaccine.
Craig’s diagnosis remains controversial — in science and politics — with others claiming similar situations. More on that below. But first, no study to date has been able to prove the mRNA vaccines can cause these neurological complications.
But, as stated earlier, there are still questions no study has been able to answer. A study from the online journal Vaccines identifies 191 people who developed a combination of chronic neurological symptoms shortly after vaccination. None had prior COVID infections nor a history of these symptoms.
Big Pharma Q1 Earnings Roundup: AstraZeneca, BMS, Merck, Sanofi
Earnings season, much like spring, is in full bloom as Big Pharma companies offer a glimpse at their performance during the first quarter of 2024.
Thus far, drugmakers have largely produced solid financials, topping expectations from analysts on Wall Street and raising full-year outlooks accordingly. A group of prominent pharma companies unveiled their respective earnings Thursday morning, with some soaring and others reeling.
AstraZeneca reported $12.6 billion in total revenue for Q1, up 17% from this time last year. The drugmaker’s earnings per share (EPS) rose 21% to $1.41 and its core EPS increased 7% to $2.06.
Merck beat expectations with $15.7 billion in quarterly sales, up 9% year-over-year, as well as a non-GAAP EPS of $2.07, up 48% over the same period. Merck’s net income soared 69% to $4.7 billion as perennial performers like Keytruda and Gardasil grew by double digits.
Cost of Developing New Drugs May Be Far Lower Than Industry Claims, Trial Reveals
Doctors have for the first time released details of their spending on a major clinical trial, demonstrating that the true cost of developing a medicine may be far less than the billions of dollars claimed by the pharmaceutical industry.
Médecins Sans Frontières (MSF) is challenging drug companies to be transparent about the cost of trials, which has always been shrouded in secrecy. Its own bill for landmark trials of a four-drug combination treatment for drug-resistant tuberculosis came to €34m (£29m).
Bedaquiline, a new drug with a different mechanism against drug-resistant TB, was developed by Johnson & Johnson and, in 2012, became the first TB drug to be approved by the Food and Drug Administration in the U.S. in 40 years. But the cost was prohibitive for many of the worst-affected countries. It took a long battle by campaigners to get the price reduced. The cost of R&D was a key factor. Eventually, it was revealed by academics that the drug was developed thanks to public funding, which was five times more than private investment.
Merck Beats Earnings Expectations, Raises Outlook on Strong Keytruda and Vaccine Sales
Merck on Thursday reported first-quarter revenue and adjusted earnings that topped expectations as it posted strong sales of its blockbuster cancer drug Keytruda and vaccine products. The pharmaceutical giant also raised and narrowed its full-year revenue and adjusted earnings forecasts. Merck now expects 2024 sales to come in between $63.1 billion and $64.3 billion, up from previous guidance of $62.7 to $64.2 billion.
The company posted a net income of $4.76 billion, or $1.87 per share, for the first quarter. That compares with a net income of $2.82 billion, or $1.11 per share, during the year-earlier period.
Merck’s immunotherapy Keytruda, which is used to treat several types of cancer, largely drove the growth. Keytruda generated $6.95 billion in revenue during the quarter, up 20% from the year-earlier period.
Merck also reported a jump in sales of Gardasil, a vaccine that prevents cancer from HPV, the most common sexually transmitted infection in the U.S.
U.S. Study Shows Post-COVID Rebound in Inappropriate Antibiotic Prescribing
An analysis of outpatient antibiotic prescribing in the United States from 2017 through 2021 shows that rates of inappropriate prescribing returned to baseline levels following a brief dip at the beginning of the COVID-19 pandemic, U.S. researchers reported this week in Clinical Infectious Diseases.
Among the 60.6 million antibiotics dispensed during the study period, 15.6% were appropriate, 29.4% were potentially appropriate, 25% were inappropriate, and 30% were not associated with a recent diagnostic code.
The proportion of enrollees with one or more inappropriate prescriptions was 1.7% in December 2019. In April 2020, it dipped to 0.9%. But by December 2021, the proportion of enrollees with one or more inappropriate antibiotic prescriptions was back to 1.7.%. Notably, from March 2020 through December 2021, one of the two most common diagnoses among people who received inappropriate antibiotics was “contact with and suspected exposure to COVID-19.”
Utility Therapeutics Wins FDA Nod for UTI Antibiotic That Has Been on the Market in Europe for 40-Plus Years
For the first time in more than 20 years, the FDA has approved a treatment for uncomplicated urinary tract infections (uUTI). And the nod has come for an oral antibiotic that has been available in Europe for more than 40 years.
It’s an odd set of circumstances and a dose of foresight by Utility Therapeutics that bring Pivya (pivmecillinam) to the market in the United States in the therapy’s golden years. The London-based company was formed specifically to develop and commercialize pivmecillinam in the U.S. where antimicrobial resistance is growing to standard-of-care antibiotics.
The decreased “utility” of first-line antibiotics and the void the company is attempting to fill in the U.S. were the inspiration of the name of the company. And the void is significant as more than 30 million uUTIs are diagnosed every year in the U.S., with nearly half of all women contracting the infection at some point in their life. Outside of the hospital setting, UTIs account for more antibiotic use than any other disorder.
AstraZeneca Leaps After Smashing First-Quarter Forecasts
AstraZeneca (AZN.L) sailed past market expectations for quarterly revenue and profit on Thursday, boosted by demand for its blockbuster drugs and steady sales from partnered medicines and sending its shares up over 5%.
CEO Pascal Soriot has rebuilt the company’s pipeline of new drugs since taking the helm more than a decade ago, with blockbusters such as lung cancer drug Tagrisso, leukemia drug Calquence and Farxiga for diabetes.
